Devices for conducting subperiosteal minimally invasive aesthetic jaw bone grafting augmentation and their use

ABSTRACT

Devices for carrying out subperiosteal minimally invasive jaw bone augmentation and reconstruction procedures, to develop a passageway and surgical site in a concealed area of patient tissue, where the surgical site is not exposed. The devices have shanks with specially configured tips to facilitate maneuvering the device through mammalian tissue to develop a tunnel in the tissue and a remote surgical site within the tissue. The device tips have one or more peripheral cutting surfaces that direct the positioning of the tunnel formation when the instrument handle is manipulated, e.g., by rotation, angular, forward or rearward motion. Embodiments of the devices are configured with tips that have a wide spread for cutting and elevating tissue, and with tips that may be maneuvered to condense bone graft material being implanted at a surgical site concealed within the tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 15/493,961, filed Apr. 21, 2017, and claims the benefit under35 U.S.C. 119 and 35 U.S.C. 120 of International patent applicationSerial No. PCT/US17/25478, filed Mar. 31, 2017, and U.S. provisionalapplication Ser. No. 62/316,140, filed Mar. 31, 2016, each entitled“Method, Devices And Articles For Conducting Subperiosteal MinimallyInvasive Aesthetic Jaw Bone Grafting Augmentation”, the completecontents of which are herein incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to instruments and devices for minimallyinvasive reconstruction of the jaw, namely bone, soft tissue, gingivalpapillae and the attachment apparatus whereby teeth and dental implantsare attached to the jaw bone, and more particularly to instruments thatare used to perform subperiosteal augmentations and reconstructions,implantable jaw bone graft substrates, and their use in carrying outprocedures, such as, subperiosteal augmentations and reconstructions,implantable jaw bone graft substrates, where bone material is implantedthrough the mucosal tissue

BRIEF DESCRIPTION OF THE RELATED ART

The human jaw bone is the supporting structure for teeth, and may beaffected by a number of conditions, including age, congenitalabnormalities, medical treatments, injuries, disease and trauma. Thehuman lower jaw bone is referred to as the mandible, and the upper jawis known as the maxilla. In a number of instances, the mandible andmaxilla may change as a person ages. Reconstructions of the mandible andmaxilla are carried out to correct physiologic and pathologicconditions, to remediate an aesthetic condition or appearance, or both.Subperiosteal augmentations with biomaterials to reconstruct the jawbone may be used in individuals that have a shallow jaw bone, or jawbone deficits due to congenital factors, disease or trauma.

Aesthetic outcomes in implant therapy are predominantly dependent on theperi-implant soft tissue architecture. Traditional bone graftingtechniques include releasing incisions, papilla splitting, gingival flapelevation and manipulation to cover the augmented volume. Regardless ofthe degree of bone augmentation achieved, the soft tissue results ofteninclude gingival deformities leading to compromised esthetics. Arelationship between the complexity of the augmentation procedure andthe degree of peri-implant soft tissue deformity has been documented inthe literature. Typically, the more complex procedures exhibit anincrease in the level of deformity of the soft tissue. Therefore,although minimally invasive procedures have been advocated, there arecertain problems encountered that have not been resolved (i.e. verticalbone augmentation, new attachment regeneration on natural teeth orimplants, and gingival papillae reconstruction).

Instruments typically are provided for use with open incisions. Openincisions expose the surgical site and provide access to thesubperiosteal tissue, bone and/or graft material at the surgical site towhich the instrument may be guided for use at that location. However, itis advantageous to implement alternative surgical procedures where aremote incision is made, and a tunnel is surgically developed betweenthe remote incision and the surgical site where bone graft material isto be implanted. The use of conventional instruments do not provide thecapability required to maneuver through the tunnel to the surgical site,and manipulate material at the surgical site, such as tissue and bonegraft material, by controlling the instrument from a location outside ofthe remote incision. Prior instruments are provided to directly accessan exposed surgical site that is accessible from an incision at thesite. The present instruments are designed to reduce trauma byminimizing the damage the tissue at the surgical site where healing isrequired after the deposit of the bone graft material.

A need exists for devices that are useful for carrying out subperiostealprocedures, where the surgical site is remote from an incision, is notfully exposed, and where direct access to the surgical site is notavailable. The present invention avoids many of the foregoing problemsand permits a more effective means to minimize the invasiveness ofsubperiosteal augmentations and reconstructions, as well as the numberof procedures, morbidity and cost for treatment applications.

SUMMARY OF THE INVENTION

Devices for use in carrying out surgical procedures are provided, and inparticular, devices configured for use in carrying out subperiostealminimally invasive aesthetic jaw bone augmentation and reconstruction.The devices are configured for use at surgical sites that are notexposed. The devices designed for use in jaw reconstruction procedures,such as mandibular and maxillary reconstructions including horizontaland vertical bone augmentations. The inventive devices or instrumentsmay also be employed to facilitate reconstruction and regeneration ofthe apparatus consisting of alveolar bone, periodontal ligament and rootcementum, whereby teeth and dental implants are attached to the jawbone, and the gingival papillae also is reconstructed and/orregenerated, through the implementation of procedures that utilize theinventive devices to manipulate the tissue to accept implantablebiomaterials. The devices include instruments configured with engagingportions configured as elevators and condensers that may be used tocarry out reconstruction and augmentation procedures, includingreconstructions of horizontal and vertical jaw defects, regeneration ofthe structures and apparatus whereby teeth and dental implants areattached to the jaw bone in addition to the reconstruction of gingivalpapillae, may be achieved with the minimally invasive method,instrumentation, and articles, including the implantable biomaterials,of the invention. Preferred embodiments of the instruments havespecially configured portions that permit maneuvering to direct theinstrument along a preferred path, which may be linear, non-linear of acombination of both, to generate a passageway or tunnel leading to asurgical site that is concealed within the tissue.

The devices are configured for use in carrying out alternative surgicalprocedures, where the device is maneuvered from a location remote of thesurgical site, and preferably from outside of the patient tissue. Forexample, the inventive devices may be used in jaw reconstruction andaugmentation procedures where a remote incision is made in the patient'smucosa. The devices may be used to make an incision and to surgicallydevelop a tunnel in the mucosa that leads from the incision to asurgical site where bone graft material is to be implanted. The devicesalso may be used at the surgical site to prepare the surgical site toreceive a bone graft. The devices are configured to reduce potentialdamage to the patient tissue by providing the capability for a user tosurgically develop a tunnel in the patient mucosa by maneuvering thedevice in a direction desired by the user. The devices may be insertablethrough the tunnel to the surgical site.

The devices are configured with shanks and associated tips that aredesigned to allow use from outside of the surgical site and incision.The instrument may include ends that have cutting edges on a portion ofor on the entire tip perimeter, to facilitate cutting of the tissue. Thetips are specially configured to provide controlled intrusion into themucosa to form a tunnel in a location directed by the instrument user.Preferred embodiments of the instruments may be used to form a tunnel inthe mucosa, and are configured to elevate the periosteum as the usermoves the instrument forward to develop the tunnel. The instruments maybe moved forward and rearward, and may be rotated or turned tomanipulate the tissue and bone graft material at the surgical site. Theuser of the instrument may maneuver and manipulate the instrument from alocation outside of the remote incision, where the instrument tip orhead, carried on the shank, is engaging implant material (bone graftmaterial) and/or tissue to form the tunnel, or at the remotely situatedsurgical site. The instrument tip leading portion as well as lateralportions may be used for cutting, elevating, and/or manipulatingstructure, such as tissue, bone and bone graft material. The instrumentsprovide the capability to access a concealed surgical site through aremote incision, and to form a tunnel, and access the surgical sitethrough the tunnel tissue without the need to open the tunnel tissue onall sides. The instruments, for example, may be used to create theincision and to develop the tunnel. In addition, an instrument may beused to form the remote incision, as well as to be inserted into theincision and form the tunnel in the mucosa. In addition, the instrumentsmay be inserted through the incision connecting to the tunnel, and maythen be maneuvered through the tunnel to the surgical site. At thesurgical site, an instrument may be controlled to maneuver the handle,which remains outside of the surgical site. Instrument manipulation mayinclude rotation, as well as insertion to provide pressure from adesired angle or direction on the tissue, bone graft material, patientbone, or other fixture or structure at the surgical site. Bone graftmaterial may be made from a mammalian or mineral material, and may beprocessed with one or more agents. Some examples of bone graft materialinclude human, bovine, equine, porcine or other mammalian bone,anorganic bovine bone (e.g., non-living bone), as well as anorganichuman, mammalian or mineral bone particles that are mixed with abiologic agent containing growth factors, biologic adhesive or bindingsubstances.

Embodiments of the instruments, according to preferred configurations,provide the instruments with the capabilities for elevating the tissueor for condensing the tissue or bone structure. For example, someinstruments may be configured with an elevator tip end that permits theraising of the mucosa of a surgically developed tunnel. The instrumentpreferably provides the tip at the end of a specially configured shankthat is connected to the instrument handle. The manipulation of thehandle may produce movements of the tip as a result of the shankconfiguration and tip geometry relative thereto. Movements may includeapplication of an elevating effect from a direction inside the tunnel,which may be elevating relative to the bottom or a side of the tunnel,or relative to another tunnel position. The instruments may include acondensing end configured on a shaft, so that movements of the handlemay effect condensing by application of a condensing force of the bonegraft material. The condensing force may be applied toward the patient'sexisting bone (mandibular or maxillary), or relative toward anotherdirection (such as against implanted bone graft material).

The present instruments are useful for carrying out subperiostealprocedures where the surgical site is remote from an incision, and notfully exposed to the instruments, and is concealed beneath the tissuesurface. Once the jaw bone is reconstructed using the instruments tocarry out minimally invasive reconstruction methods, and biomaterialsare implanted, then dental implants (e.g., prosthetic teeth), may beplaced to restore function. The instruments provide the capability todevelop an appropriately directed tunnel within the patient tissue, toaccess to the remote surgical site through a tunnel, and to maneuver adeposit of bone graft material in a desired configuration or orientationso as to restore or augment the patient's existing bone. The instrumentsare used to carry out minimally invasive reconstruction of horizontaland vertical jaw defects, where bone replacement or augmentationpromotes or produces the regeneration of the structures and apparatuswhereby teeth and dental implants may be attached to the jaw bone, inaddition to the reconstruction of gingival papillae.

The instruments may be used to sculpt bone graft material that isdelivered to the remote surgical site (e.g., through a tunnel developedin the mucosa), which, for example, may involve bone particles, bonepastes, as well as customized granular or molded bone grafts orbone/collagen grafts in different configurations (such as graft molds,shapes and blocks, configured in different designs, compositions anddimensions). For example, the instrument configured with a condensingtip may be used to manipulate the bone graft material to form a desiredposition and/or orientation at the surgical site, and in other areaswhere manipulation of the bone material may be required (the tunnel).

The inventive instruments preferably are configured to produce elevatingand condensing effects in the bone graft material and tissue, and may beused to carry out surgical procedures that include making an incision,which may be remote of the surgical site, developing a tunnel in alocation in the tissue (below the periosteum) to form a passageway fromthe remote incision to the surgical site. The instruments also may beused to configure the surgical site to receive bone graft material. Theinstruments are specifically configured for use in forming asubperiosteal pouch at the surgical site by maneuvering the instrumentto elevate the periosteum of the surgical site forming a pouch that willhouse and confine a graft. The instruments may be used to manipulate thetissue to form a subperiosteal pouch having a suitable configuration(such as the size and shape) to house a bone or bone/collagen graft thatis to be located and installed at the site. The instruments may be usedto manipulate the tissue to configure the pouch so that it will receiveand confine the graft and maintain the graft in a desired position.

In carrying out bone augmentation or reconstruction procedures, theinstruments may be used to manipulate bone graft material that isdelivered to a surgical site (by a carrier). This may be done bycondensing and adapting the graft material to achieve the degree of boneaugmentation desired.

According to preferred embodiments, the instruments are configured withan elevator, condenser or spatula like tip, to carry out condensing ofthe bone material. Instruments according to embodiments of the inventionmay be provided having a holding area and double or single ends, onwhich an engaging element, such as, a condensing element or elevatingelement is provided. The condensing element or tip preferably isconnected to a shaft or shank which connects with the instrument handle.The instrument is configured so that it may be used to providemaneuverability of the tip, such as a condensing element (which may beprovided at each end thereof), so that the condensing element may beinserted into the remote incision and maneuvered through the tunnel andat the surgical site where the bone graft material (such as boneparticles, bone paste, or bone articles) is positioned. The condenserhas a configuration that permits manipulation using the instrumenthandle so that the condenser tip may pack the bone graft into the site.Other instruments may be configured with tips that may be maneuvered tomold the bone material into an appropriate shape.

Upon completion of the installation of the bone graft and condensationand adaptation in place at the site, or upon the completion of a stepthat requires the use of a different one of the instruments, theinstrument is removed by withdrawing it from the surgical site, whichmust be done by retracting the instrument from the tunnel. According tosome embodiments, the instruments may be configured to provide one ormore rounded or non-incisive structures that engages the tissue andraises it away from the sharp or cutting edges of the instrument tip.The user may retract the instrument from the tissue, for example, whenan instrument is being withdrawn from a tunnel and minimize the tendencyfor undesired cutting. Since the instrument movement may be maneuveredat different angles, according to some preferred embodiments, someperipheral, upper or lower edges of the instrument shank or tip may besoftened or rounded to minimize or prevent undesirable damage to thetissue surrounding the tunnel passageway.

The instruments are configured to be used to carry out a procedure at asurgical site remote from an incision into which the instrument isinserted, so that upon completion of a procedure, the incision may beclosed, preferably by suturing or by utilizing another suitabletechnique.

The present devices are designed to minimize or eliminate potentialperi-implant soft tissue disfigurement. The devices and their use alsoprovide a way to achieve consistency in horizontal and verticalaugmentation of the jaw. The devices are designed to be utilized toimplement procedures without losses to bone volume, and preferably, arealso designed to permit less invasive techniques for providing bonevolume that traditionally was achievable only with flap based or opensurgical techniques (that involve direct placement of a tool at thesurgical site, as opposed to through a tunnel). The devices improvepredictability, and may reduce the need for the number of procedures,morbidity as well as costs.

According to preferred embodiments, the inventive instruments may beused to carry out restorations and augmentations, including, forexample, vertical augmentation applications involving the jaw, which maybe performed at both, mandibular and maxillary locations. The devicesmay be utilized to provide subperiosteal augmentation of the jaw withoutthe need for the use of a membrane, such as a cell-occlusive membrane orspace maintaining membrane, and without the step of installing themembrane. The devices also may be used to facilitate jaw boneaugmentation methods that are carried out without the use of tentingscrews or other space maintaining devices such as a titanium mesh andtitanium reinforced membranes.

According to some preferred embodiments, the instruments are configuredas a tunneling instrument that may be utilized to make the incision,develop the tunnel, and operate at the active site by forming a pocketfor the graft and carrier. The tunneling instrument may be formed with acutting portion that is disposed on a maneuverable arm that permits thetunnel formation by maneuvering the instrument arm and cutting portionthrough the tissue. The tunneling instrument may be configured as anelevator that may include a specially designed cutting portion at thetip to facilitate the separation of an intact periosteum layer. Forexample, according to some embodiments, the tunneling instrument may beconfigured for use in forming a subperiosteal pouch. According topreferred embodiments, the instrument may include one or more mechanismsthat may be utilized to maneuver or manipulate the periosteum to createthe pouch.

According to some preferred embodiments, the instrumentation may beprovided in the form of a kit or separate kits which includes thecomponents and mechanisms that may be utilized for carrying out themethod. According to some preferred embodiments, the instrumentation isprovided as a kit or separate kits which may be adapted to pre-existinginstruments, and/or steering and viewing devices. According to someother devices, the instrumentation may be a complete kit which includesone or more displays, mechanisms for steering and moving the cutting andgrasping elements of the instruments.

The instruments preferably are constructed to facilitate the pouchformation in a subperiosteal augmentation or restoration by enabling theuser to manipulate the instrument to elevate the subperiosteal tunnel.The pouch is created to house and confine a graft, and the instrumentsmay be used to configure the pouch within the periosteum, e.g., thedense layer of vascular connective tissue surrounding the mandibleand/or maxilla. The instruments may be used to elevate the tunnelpreferably at the location where the bone graft is to be installed inorder to prepare the site for the reception of the grafting materialthat is to be delivered to the location (e.g., bone graft granules,paste, or a prefabricated bone graft).

The present devices may be used for jaw augmentation and restorationprocedures and in particular, to carry out procedures that are designedto be less invasive than prior methods. According to preferredembodiments, the instruments may be used to carry out subperiostealaugmentations and reconstructions in the maxillary anterior region withminimal or no risk of disfigurement to the patient.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1A is a top plan view of an exemplary embodiment of deviceaccording to the invention configured as an elevator.

FIG. 1B is a right side elevation view of the device of FIG. 1A.

FIG. 1C is an enlarged partial view of the device of FIG. 1A, showingthe tip end.

FIG. 1D is an enlarged partial view of the device of FIG. 1A, shownrotated about 90 degrees from the position in FIG. 1B.

FIG. 2A is a top plan view of an alternate embodiment of a deviceaccording to the invention configured as an elevator, being similar tothe device of FIG. 1A, having a longer reach.

FIG. 2B is a right side elevation view of the device of FIG. 2A.

FIG. 3A is a top plan view of a third alternate embodiment of deviceaccording to the invention configured as an elevator.

FIG. 3B is a right side elevation view of the device of FIG. 3A.

FIG. 4A is a top plan view of a fourth alternate embodiment of deviceaccording to the invention configured as an elevator, being similar tothe device of FIG. 3A, having a longer reach.

FIG. 4B is a right side elevation view of the device of FIG. 4A.

FIG. 5A is a top plan view of a fifth alternate embodiment of a deviceaccording to the invention configured as an elevator.

FIG. 5B is a right side elevation view of the device of FIG. 5A.

FIG. 6A is a top plan view of a sixth alternate embodiment of a deviceaccording to the invention configured as an elevator, being similar tothe device of FIG. 5A, having a longer reach.

FIG. 6B is a right side elevation view of the device of FIG. 6A.

FIG. 6C is an enlarged partial view showing the shank end and tip of thedevice of FIG. 6A.

FIG. 7A is a top plan view of a seventh alternate embodiment of deviceaccording to the invention configured as an elevator.

FIG. 7B is a right side elevation view of the device of FIG. 7A.

FIG. 8A is a top plan view of an eighth alternate embodiment of deviceaccording to the invention configured as an elevator, being similar tothe device of FIG. 7A, having a longer reach.

FIG. 8B is a right side elevation view of the device of FIG. 8A.

FIG. 9A is a top plan view of a ninth alternate embodiment of deviceaccording to the invention configured as a condenser.

FIG. 9B is a right side elevation view of the device of FIG. 9A.

FIG. 9C is an enlarged partial view showing the shank end and tip of thedevice of FIG. 9A

FIG. 10A is a top plan view of a tenth alternate embodiment of deviceaccording to the invention configured as a condenser, being similar tothe device of FIG. 9A, having a longer reach.

FIG. 10B is a right side elevation view of the device of FIG. 10A.

FIG. 11A is a top plan view of an eleventh alternate embodiment ofdevice according to the invention configured as a compactor.

FIG. 11B is a right side elevation view of the device of FIG. 11A.

FIG. 11C is an enlarged partial view showing the shank end and tip ofthe device of FIG. 11A.

FIG. 12A is a top plan view of a twelfth alternate embodiment of deviceaccording to the invention configured as a compactor, being similar tothe device of FIG. 11A, having a longer reach.

FIG. 12B is a right side elevation view of the device of FIG. 12A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1A-1D are views of an exemplary embodiment of an elevator 111according to the invention, FIG. 1A showing a top plan view, FIG. 1Bshowing a side elevation view, and FIGS. 1C and 1D showing respectiveend views of the element of the respective instrument end.

Referring to FIGS. 1A to 1D, what is illustrated is a device comprisinga dental surgical instrument 110 for use in carrying out a subperiostealaugmentation or reconstruction procedure involving the creation of anincision, insertion of the instrument 110 through an incision remotelysituated from a surgical site where bone is to be implanted, and themaneuvering of the instrument 110 through the tissue to develop a tunnelwithin the periosteum that leads to the surgical site. The instrument110 includes cutting edges provided on the tip 113, and may be used toprepare the surgical site to receive bone graft material.

The dental instrument 110 is shown configured as an elevator. The dentalinstrument 110 includes a handle 111, an elongate shank 112 connected tothe handle 111 at the proximal end 112 a of the shank 112 and beingshown extending from the barrel shaped handle body 111 a. A tip 113 isprovided at the distal end 112 e of the elongate shank 112. The handle111 may be provided with a surface treatment or structure to facilitateholding and grasping of the instrument, some examples of which includeknurlings, flutings or other elements to enhance gripping of theinstrument. In the exemplary embodiment illustrated, the device 110 isshown having a knurled surface structure, such as the bands 114,provided on the exterior of the cylindrical or barrel shaped handle body111 a to facilitate holding and grasping the instrument 110 (e.g., froma package, tray and/or during use). The barrel shaped handle body 111 aincludes a reduced diameter portion 111 b provided at the handle endwhere the shank 112 is shown connecting with the handle 111. Accordingto some embodiments, the shank 112 preferably may be elongated to spaninside the handle 111, and preferably is secured within the handle 111.According to some embodiments, the shank 112 may be coextensive with aportion of the handle 111, or all of the handle 111, and according toembodiments, may span through the handle 111 to provide a second shank122 extending from the opposite side of the handle 111. For example, thefirst shank 112 and second shank 122 may be separate, or may be formedfrom a single elongated structure. According to some alternateembodiments, the first shank 112 or the second shank 122, or both, maybe formed with the handle 111, as a single piece. Alternatively, theinstrument 110, although shown having a shank 112, 122 at each endthereof, may be constructed with a single shank (112, or 122), and maybe provided as two separate instruments.

The shank 112 has a larger diameter portion 112 a closest to where theshank 112 joins the handle 111. The shank diameter is shown tapering toa smaller diameter 112 b, moving from the handle 111 to the distal endof the shank 112 where the tip 113 is located. The tip 113 is providedon the distal end 112 e of the shank 112 and is shown at the end of theshank shaft 112 c. Referring to FIG. 1B, as seen from the side view, theshank 112 has a slight gentle curvature 112 d to the shank shaft 112 c.As shown in the exemplary embodiment of the instrument 110, the shankshaft 112 c is free from sharp angles.

In the instrument embodiment illustrated in FIGS. 1A-1D, the first tip113 at the shank distal end 112 e is shown having a triangular shape.The tip 113 extends at an angle to the central axis A of the shank shaft112 c, as shown in the side view in FIG. 1B. Preferably, the angulardisposition of the tip relative to the shank shaft 112 c central axis Ais from about 20 to 70 degrees, and more preferably from between about40 to 60 degrees. The tip preferably has a concave or flat bottomsurface 113 a (FIG. 1B) and has a convex top surface 113 b (FIG. 1A).According to some preferred embodiments, the shank shaft 112 c, as shownin the side view of FIG. 1B, curves above the central axis A and returnsbelow the central axis A. Preferably the tip 113 is provided to residebelow the central axis A when the device 110 is oriented as shown in theside view of FIG. 1B. The tip 113 is configured with curved edges, whichpreferably are sharp along the perimeter and comprise a cutting edge orcurved cutting periphery designed to be used for cutting whenmanipulating the tool (through tissue or into bone). The tip 113 has aproximal edge 113 f that meets the distal end 112 e of the shank shaft112 c, which preferably may be rounded and smooth. According to apreferred configuration, the top plan view of FIG. 1A shows the tiptapering from a narrow width where the tip joins the shank shaft 112 c,widening toward a location 113 d just before the tip end 113 e.According to some preferred embodiments, the widest portion of the tip113 is located about two thirds of the distance from the start of thetip 113 to the tip end 113 e, which in the embodiment illustrated isrepresented by the tip location 113 d. The tip 113 is shown having apreferred shape which is triangular, and preferably a rounded or curvedtriangle, such as a tear drop shape.

The shank 112 preferably is provided having a suitable length thatprovides sufficient penetration depth to pass through a subperiostealtunnel and reach the intended surgical site. According to some preferredembodiments, the shank 112 may have lengths between about 30 to 85 mm,and more preferably from between about 35 to about 65 mm. According toan exemplary embodiment, the instrument 110 may be configured having ashank radial dimension from about 1 mm to about 2 mm, with the largediameter shank portion (112 a) being about 3 to 8 mm in diameter, andthe narrower shank portion (112 b) diameter, where the shank shaft 112 cjoins with the tip 113, being about 1 to 5 mm, and preferably about 2.5mm. The bottom tip surface concavity 113 a preferably has a radius ofcurvature and the upper or convex top surface 113 b preferably has aradius of curvature, examples of which are illustrated in the exemplaryembodiment shown in FIGS. 1A-1D.

Although the instrument 110 may be constructed with a shank 112 having alength suitable to reach the intended surgical site through the incisionand the length of the tunnel, according to some embodiments, the shank112 may be from about 30 to 60 mm. The instrument 110 may be constructedin different sizes to provide shank lengths that are longer or shorter.The medical personnel user may select an instrument based on the lengthrequired for the procedure. Referring to FIGS. 1A and 1B, the shank 112may be provided having a length of from about 30 to 60 mm, and accordingto one preferred embodiment, the shank length is about 35 mm. The tip113 preferably may be provided with a suitable diameter or width foruse, and according to a preferred embodiment, may have a width at itswidest dimension to be about 4.5 mm.

The outer surface of the shank 112 preferably may include a series ofevenly spaced markings which may be visibly provided thereon to mark thedepth from the tip end 113 e to the marking indicia of the shank 112, soas to provide a depth indication to the user when the instrument 110 isinserted in a subperiosteal tunnel, as to the instrument penetrationdepth.

The elevator instrument 110 preferably provides the specially configuredtip 113 at its leading end for elevating the mucosal tissue along theincision, which preferably involves elevating the mucosal tissue alongthe tunnel leading to the surgical site or pouch, the tunnel being thepathway through which the bone graft material will be delivered to thesurgical site (which is the pouch to receive the bone graft material).The tip may be presented to the tissue to form an incision using thesharp peripheral tip edge. The instrument tip 113 may be further guidedthrough the tissue by the user, so that the instrument 110 is movedalong with the tip and shank entering the tissue, and elevating thetissue as the user maneuvers and manipulates the instrument to form atunnel in the periosteum.

As shown in the figures, the tip 113 preferably is offset from theinstrument 110 central axis A (see FIG. 1B) to facilitate elevation ofthe mucosal tissue bordering the tunnel. The shank 112 preferably issmooth and has rounded edges, and may be cylindrical or radial inconfiguration so as to further facilitate insertion and maneuvering ofthe shank 112 through the mucosal tissue.

According to preferred embodiments, the shank 112 may be configuredhaving a larger cross-sectional diameter at the shank 112 proximal end112 a (the shank portion nearest to the handle 111), which may taper ornarrow over the length of the shank 112 to the tip 113, or,alternatively, which may taper to a location along the shank 112,proximal from the tip 113.

According to preferred embodiments, the instruments may be constructedwith two usable ends. The instrument 110 shown in the exemplaryembodiment includes a second shank 122 provided at the instrument endopposite the first shank 112. The second shank 122 has a tip 123, and inthe embodiment illustrated, has a configuration that is different fromthe first tip 113 on the opposite end. The second tip 123 may be formedon the end of the second shank 122, and the second shank 122 may be thesame as the first shank 112 in terms of dimensions and configurations,or, may be different. Preferably, the second shank 122 is configured tohave suitable dimensions, like the first shank 112, so as to be usefulto develop a tunnel within the periosteum and maneuver therein. In theexemplary embodiment depicted, the second shank 122 extends from thebarrel shaped handle body 111 a in the direction opposite the extensionof the first shank 112. The tip 123 is provided at the distal end of theelongate second shank 122. The second shank 122, similar to the firstshank 112, is shown having a larger diameter portion 122 a closest towhere the second shank 122 joins the handle 111, preferably, at thehandle second reduced diameter portion 111 c (provided at the handle endopposite the first reduced diameter portion 111 b). The diameter of thesecond shank 122 is shown tapering to a smaller diameter 122 b, movingfrom the handle 111 to the distal end of the shank 122 where the tip 123is located. The tip 123 is provided on the shank distal end 122 e and isshown at the end of the shank shaft 122 c. Referring to FIG. 1B, as seenfrom the side view, the second shank 122 is provided with a slightgentle curvature 122 d to the shank shaft 122 c, and, preferably, isfree from sharp angles.

In the embodiment illustrated, the second tip 123 at the second end ofthe handle 111 is shown configured as a fan shape, where the proximaltip portion 123 a joining with the shank shaft 122 b is configured as anarrower portion, and, from that point distally, the tip 123 widens,fanning out, so that the wider portion of the tip 123 is located at apoint along the tip axis that is between the distal end of the tip 123 eand the proximal end 123 a that joins with the shank 122. As shown bestin FIG. 1C, the second tip 123 has a proximal tip portion 123 b and adistal tip portion 123 c. For example, the enlarged view of the tip 123is shown in FIG. 1C, and illustrates the tip having a wide portionformed by a diameter, and a leading portion or distal portion 123 c withan arcuate profile 123 f. The arcuate profile 123 f comprises a sharpedge 123 g for cutting (e.g., soft and hard tissue, and bone) which, inthe exemplary embodiment illustrated, may be defined by a radius. Forexample, according to some preferred embodiments, the diameter may forma width of the fan shaped tip 123, and may form the widest point, andthe leading or distal portion 123 c may be formed as a divergent body,such as for example, having a semi-circular, arcuate, curved partialoval, or partial elliptical shape, and in particular, having a peripheryof such a shape. The proximal portion 123 b of the tip 123, locatedbetween the wide width (where, in the embodiment illustrated, edges 123i, 123 k are located) and the shank 122, preferably may be inwardlytapered, and preferably may be configured with inwardly directed curvededges, such as the curved edges 123 i, 123 j, which are concave relativeto a central axis of the tip 123. Referring to FIG. 1D, the tip 123 alsois illustrated having a preferred bend or angle 123α, which preferablyis relative to the central axis A of the portion of the shank 122 c towhich the tip 123 joins. The angle 123α is formed by the central axis Aof the shank portion 122 c and the central axis of the tip AT, and isshown measured relative to the upper surface 123 m. Preferably, theangle 123α is less than 180 degrees, and more preferably is betweenabout 120 to 170 degrees. The tip 123 provides the instrument 110 withthe capability to cut through tissue and bone by maneuvering theinstrument 110, via manipulation of the handle 111 (e.g., forward,axially right or left, or angularly). The instrument 110, for example,may be used to construct a tunnel in the mucosal tissue that leads tothe surgical site within the periosteum where implantable bone graftmaterial will be deposited. The instrument tip 123 facilitates movingthe instrument 110 in a forward direction to move the shank forward inthe structure, such as tissue, and directing the tunnel formation alonga desired path, which may be linear or non-linear. For example, theinstrument 110 may be used to develop a tunnel within the periosteum ofthe tissue, and the divergent end of the tip 123 is configured toelevate the tunnel when forming the tunnel so as to facilitate directingthe location where the tunnel will be developed. The instrument tip 123also includes edges 123 k, 123 l on opposite ends where the arcuate fanlike portion 123 f, or distal portion of the tip 123, meets with theproximal arcuate portions 123 i, 123 j, respectively. The edges 123 k,123 l facilitate manipulations of the instrument 110 to direct cuttingin a desired path, such as occlusal or lingual direction. The edges 123k, 123 l preferably may be sharp corners, or alternately may be curvededges, and sharp corners, or alternative curved edges, may be providedwith a cutting periphery. The proximal arcuate portions 123 i, 123 j,respectively, preferably are not required but could be provided with acutting periphery. For example, the instrument 110 may be used todevelop a tunnel in the mucosal tissue that may be directed along anon-linear path. According to a preferred embodiment, the tip 123 has anupper surface 123 m and a lower surface 123 n. As shown in the exemplaryembodiment, the upper surface 123 m may be concave, and the lowersurface 123 n may be flat or preferably may be convex.

As discussed above in connection with the first shank 112, the secondshank 122 may have a similar dimension or length. For example,embodiments of the instrument 110 may provide the second shank 122having a length of from about 30 to 60 mm. According to one preferredembodiment, the shank length may be about 35 mm. The tip 123 preferablymay be provided with a suitable diameter or width for use, and accordingto a preferred embodiment, may have a width at its widest dimension,where the fan is spread out, to be about 4.5 mm. According to someembodiments, the instrument 110 may be constructed with different tips,such as the first end tip 113 and second end tip 123 shown in theinstrument 110. The tips also may be provided having the same widthdimension at their widest point, such as the 4.5 mm dimension,referenced in an exemplary embodiment for the triangle or tapered firsttip 113 and for the fan shaped second tip 123.

According to an alternate embodiment, as illustrated in FIGS. 2A-2B, anembodiment of an elevator instrument 210 is shown. The elevatorinstrument 210, in the exemplary embodiment, is similar to theinstrument 110 of FIGS. 1A and 1B, except that the shank 212 is longer,and has a longer shank shaft 212 c. The shank shaft 212 c on the firstend of the instrument 210 is longer in relation to the embodimentdepicted in FIGS. 1A and 1B, so as to position the tip 213 distallyfurther from the handle 111. According to some embodiments, the lengthof the shank 212 may be provided from between about 40 to 80 mm, and inan exemplary embodiment, the length of the shank 212 may be about 45 mm.The second end of the instrument 210 includes a second shank 222, whichis longer than the second shank 122 of the instrument 110 shown in FIGS.1A and 1B. The second shank 222 also may be provided having a dimensionsimilar to the first shank 212. The embodiment of the instrument 210 isshown having shanks 212, 222 of equal length. The second end of theinstrument 210 includes shank 222 that is comprised of a shank shaft 222c provided with a tip 223 at the distal end. The tip 223 is configuredas a fan shape, where the proximal tip portion 223 b joining with theshank shaft 222 at the proximal tip end 223 a is configured as anarrower portion, and, from that point distally, the tip 223 is shownwidening and fanning out, so that the wider portion of the tip 223 isthe tip distal portion 223 c.

The first tip 213 of the instrument 210 is shown configured having atriangular shape, being wider at the tip proximal portion 213 b wherethe tip 213 joins the shaft 212. The tip 213 tapers and is shownconverging from the proximal end 213 a toward the distal portion 213 c,where the tip 213 e is provided having a point. According to preferredembodiments, the lateral edges 213 f, 213 g are sharp cutting edges thatmay be used to cut through soft and hard tissue as well as bone. Asshown in the side view of FIG. 1B, the first tip 213 preferably isangularly bent relative to the central axis A of the first shaft 212 c.In the embodiment illustrated, the first tip 213 is shown beingangularly disposed relative to the shank second portion 212 c″, and awayfrom the central axis A. The second shank portion 212 c″ is itself shownbeing angularly disposed relative to the first shank portion 212 c′, andbent away from the central axis A. According to a preferred embodiment,the shank first portion 212 c′ and second shank portion 212 c″ and bend212 d may lie in the same axial plane. The second tip 223 also may beprovided with a bend 222 d, similar to the bend 212 d, which may beprovided along the central axis A, with the shank first portion 222 c′and shank second portion 222 c″ forming an angular relation at the bend222 d.

Referring to FIGS. 3A and 3B, an alternate embodiment of an elevatorinstrument 310 according to the invention is illustrated. The instrument310 preferably is constructed having a handle 311, with a handle body311 a and a reduced diameter portion 311 b, 311 c, at each end thereof.The first shank 312 is shown extending from the handle body, which inthis embodiment is from the handle tapered portion 311 b, andterminating in a tip 313. The shank 312 is provided having two bends,including a first bend 312 d, which in the top view of FIG. 3A turns tothe left of, or away from, the central axis A, and a second bend 312 ethat bends back toward the axis A, to the right. According to apreferred embodiment, as depicted in the side view of FIG. 3B, the firstshank 312, and second shank 322 have bends that lie within a plane. Forexample, according to an exemplary embodiment illustrated, the firstbend 312 d and second bend 312 e bend to the left or right of the axis A(relative to the top view of FIG. 3A), but remain in the same axialplane.

The first tip 313 and second tip 323, in the instrument 310, preferablyare mirror images of each other. The tip 313 is illustrated having anelliptical configuration. Preferably, the elliptical tip 313 has anelliptical length that is greater than the elliptical width, with theelliptical length spanning in the same direction as the axis of theshank shaft 312 c to which the tip 313 is connected. The ellipticalwidth of the tip 313 preferably is the widest width of the tip takenperpendicular to the shank shaft 313 c. According to some embodiments,the elliptical tip 313 may form a tapered portion at its proximal endwhere it joins with the shank second portion 312 c″. The instrument 310is configured with a second end having a second tip 323 provided at theend of the second shaft 322. The second shaft 322 is shown extendingfrom the handle body 311 a and in particular from a tapered end portion311 c. The bends in the shank 312 preferably are provided as discussedand shown in connection with the first shank 312. A first bend 322 d andsecond bend 322 e are provided, but with mirrored orientation relativeto the bends of the first shank 312. The shank shaft 322 c moves axiallyaway and to the right (looking from the top view in FIG. 3A) of the axisA, and, at the second bend 322 e, the shank shaft 322 c moves toward theaxis A, toward the left, and crosses the axis A, and then terminates atthe tip 323. An elliptical tip 323 is provided at the distal end of theshank shaft 322 c. According to a preferred embodiment, the second tip323 is the same as the first tip 313, and preferably is an ellipticaltip. According to some embodiments, the first tip 313 and second tip 323are mirror images of each other. The first tip 313 is shown having aconcave surface 313 a on one side thereof, and preferably, has a flatsurface or convex surface 313 b (FIG. 3B) on the other side. The secondtip 323 is shown having a flat or convex surface 323 b on one sidethereof, and preferably, has a concave surface on the other side 323 a.According to preferred embodiments, the first bend 312 d and second bend312 e form two portions of the shank shaft 312 c, including a firstportion 312 c′ and a second portion 312 c″. The first portion 312 c′ isshown shorter than the second portion 312 c″. According to preferredembodiments, the shank 312 at the first bend 312 d is angled away fromthe central instrument axis A, represented by angle alpha, 310α. Theshank first portion 312 c′ meets the shank second portion 312 c″ at thesecond bend 312 e, and the shank second portion 313 c″ bends inwardlytoward the central axis A, relative to the first portion 312 c′, at anangle represented by angle beta, 310β. According to a preferredembodiment, the first angle, angle alpha, 310α, that the first portion312 c′ makes with the axis A is relatively smaller than the angle beta,310β, that the first portion 312 c′ makes with the second portion 312c″. According to a preferred embodiment, the first angle alpha (310α) isabout 30 degrees, whereas the second angle beta (310β) is about 120degrees. The angular ratio between the first angle alpha (310α) andsecond angle beta (310β) preferably may be about 1:4. As illustrated inFIGS. 3A and 3B, the second shaft 322 preferably is provided withangular bends similar to the bends described in connection with thefirst shaft 312, which preferably may be provided with similar angularrelationships.

According to a preferred embodiment, an elevator 310 is constructed withthe portion of the shank shaft 312 c between the first bend 312 d andsecond bend 312 e being about 14 mm, and with the portion between thesecond bend 312 e to the tip 313, and inclusive of the tip length, beingabout 22 mm. Similarly, the second shank 322 c may be constructed withsimilar dimensions. Each elliptical tip 313, 323, preferably is about5.5 mm in length, and has a width of about 4 mm.

According to alternate embodiments, the instrument 310 may be configuredwith a fan like tip, such as, the fan tips shown and described herein,including, for example, the tip 123 shown and described in connectionwith FIGS. 1A-1D. The instrument 310 may be configured with the bendsand shank provided with a fan like tip at one or both ends.

An alternate embodiment of an elevator 410 is shown in FIGS. 4A and 4B.The elevator 410 is similar to the elevator to the instrument 310 ofFIGS. 3A and 3B, except that each shank 312, 323 is longer, and theangles of the shank bends, the first angle alpha (410α) and second anglebeta (410β) in the instrument 410 are provided to produce less of abend. The first angle alpha (410α) of the instrument 410 is less thanthe corresponding angle (410α) of the instrument 310. The second anglebeta (410β) of the instrument 410 is greater than the second angle beta(410β) of the instrument 310. The shank shaft first portion 412 c′ onthe first end of the instrument 410 is longer in relation to the shankshaft first portion 312 c′ in the instrument 310 depicted in FIGS. 3Aand 3B, as is the second shank portion 412 c″ which is longer than thecorresponding shank second portion 312 c″ of the instrument 310. In thelonger instrument 410, the tip 413 is distally further from the handle411. The shank 412 is constructed to have less pronounced angular bendsat the first bend 412 d and second bend 412 e so as to provide a maximuminstrument width that includes deviations from the central axis A, oneither side. According to some embodiments, the axial width or windowfor the instrument 310 may be the same window as for the instrument 410,with the additional shank length being accommodated by a reduction inthe outward deviation of the shaft relative to the central axis A. Thesecond instrument end includes a second tip 423 provided at the end ofthe second shaft 422. The second shaft 422 extends from the handle 411,and preferably from the tapered portion 411 c and to where it joins thetip 423 at the distal shank end. Similar to the first shaft portion 412c′ and shank second portion 412 c″ of the first shaft 412, the secondshank shaft 422 includes a shaft first portion 422 c′ and shaft secondportion 422 c″.

According to a preferred embodiment, the elevator 410 is constructedwith the portion of the shank shaft 412 c between the first bend 412 dand second bend 412 e being about 19 mm, and with the portion betweenthe second bend 412 e to the tip 413, inclusive of the tip length, beingabout 27 mm. Similarly, the second shank 422 c may be constructed withsimilar dimensions. In a preferred embodiment, each elliptical tip 413,423, preferably, is about 5.5 mm in length, and has a width of about 4mm.

According to alternate embodiments, the instrument 410 may be configuredwith a fan like tip, such as, the fan tips shown and described herein,including, for example, the tip 123 shown and described in connectionwith FIGS. 1A-1D. The instrument 410 may be configured with the bendsand shank provided with a fan like tip at one or both ends.

Referring to FIGS. 5A and 5B, an alternate embodiment of an elevatorinstrument 510 for use in subperiosteal augmentation procedures isshown. The instrument 510 includes a handle 511, a shank 512 extendingfrom the handle 511, with a tip 513 at the end of the shaft 512. Theshank 512 includes a plurality of shank shaft portions, which in theembodiment depicted are first through fourth shank shaft portions 512c′, 512 c″, 512 c′ and 512 c″″, respectively. The shank 512 includes aplurality of bends, which from the proximal shank end to the distalshank end where the tip 513 is located, are depicted as a first bend 512d, a second bend 512 e, and a third bend 512 f. The first bend 512 d andsecond bend 512 e are on the same axis, which is in a plane parallel tothe central axis A. The third bend 512 f is provided transverse to thecentral axis A. Preferably, the third or distal bend 512 f is providedon a transverse axis, the transverse axis being represented by axis A2.The first shank first portion 512 c′ is provided coaxial with thecentral axis A. The shank second portion 512 c″ bends relative to theshank first portion 512 c′ at the first bend 512 d, and is in the sameaxial plane as the shank first portion 512 c′. The shank third portion512 c′″ bends relative to the shank second portion 512 c″ at the secondbend 512 e, and then joins the shank fourth portion 512 c″″ at the thirdbend 512 f At the third bend 512 f, however, the shank fourth portion512 c″″ bends relative to the shank third portion 512 c″′ in a differentaxial plane than the shank first portion 512 c′, shank second portion512 c″ and shank third portion 512 c′″ and the respective first andsecond bends 512 d, 512 e. The instrument 510 is shown having a tip 513that is configured similar to the fan like second tip 223 shown anddescribed in connection with the instrument 210. According to apreferred embodiment, the fan like tip 513 has an inner surface 513 athat is concave. The tip 513 may be constructed as described and shownin relation to the tip 223. In the instrument 510 depicted, the concavesurface 513 a preferably is substantially almost parallel to the handle511. According to a preferred embodiment, the second end includes asecond shank 522, which includes first through fourth shank portions 522c′, 522 c″, 522 c″′ and 522 c″″, respectively, and respective bends 522d, 522 e and 522 f, similar to the arrangement of bends and shankportions shown in the first end of the instrument 510. A tip 523 isprovided at the distal end of the shank 522. The tips 513 and 523, aredepicted being constructed similar to the second tip 223 of theinstrument 210 shown in FIGS. 2A and 2B, but are oriented as shown inFIGS. 5A, 5B. The angular bend of the fourth portion 512 c″″orients thetip 513 in a preferred direction for utilization during thesubperiosteal augmentation and reconstruction procedures. The tip 523 isconfigured as a fan shape, where the tip proximal portion 523 b joiningwith the shank shaft 522 at the proximal tip end 523 a is configured asa narrower portion, and, from that point distally, the tip 523 widensand fans out over the wider tip distal portion 523 c. The tip end 523 epreferably has a cutting edge or periphery, similar to the tip 223 ofthe instrument 210.

According to embodiments, the instrument 510 preferably is constructedwith preferred angular dimensions, including a first angle defining afirst bend 512 d, which is a bend between the first portion 512 c′ andthe second portion 512 c″, and a second angle defining a second bend 512e which is the bend between the second portion 512 c″ and the thirdportion 512 c′″, and a third angle defining a third bend 512 f which isthe bend between the third portion 512 c″′ and the fourth portion 512c″″.

According to a preferred embodiment, the instrument 510 preferably isconstructed with the fourth portion 512 c″″ being longer than each ofthe other three portions (512 c′, 512 c″ and 512 c″′). The first portion512 c′, second portion 512 c″ and third portion 512 c′″, may each havesimilar lengths. For purposes of describing the length of the firstportion 512 c′, the tapered portion 511 c of the handle 511 is includedin this measurement portion. According to a preferred embodiment, thefirst, second and third shank portions 512 c′, 512 c″, and 512 c″′,respectively, are each about 10 mm in length. The fourth portion 512 c″″inclusive of the tip 513 preferably is about 20 mm. The tip 513preferably has a length of about 4.5 mm.

Referring to FIGS. 6A and 6B, an alternate embodiment of an elevatorinstrument 610 is shown. The instrument 610 is similar to the instrument510, except that the first shank portion 612 c′ is longer than thesecond and third shank portions, 612 c″ and 612 c′″, respectively,providing an extended reach of the instrument to develop a longersubperiosteal tunnel or to extend the reach within a subperiostealtunnel. According to a preferred embodiment, the first shank portion 612c′ may be about 20 to 40 percent longer than the length of therespective second and third shank portions 612 c″ and 612 c″′. Accordingto a preferred embodiment, the length of the second, third and fourthshank portion, respectively, 612 c″, 612 c″′, and 612 c″″, are similarto dimensions discussed in connection with the instrument 510, with thefirst portion 612 c′ being provided having a length of about 14 mm.Alternatively, the second portion 612 c ″ may be provided having agreater length, and, according to a preferred embodiment, may be about12 mm in the example depicted in FIGS. 6A and 6B, where the firstportion 612 c′ is about 14 mm, the third portion 612 c′″ is about 10 mmand the fourth portion 612 c″″ including the tip 613 is about 20 mm.

Referring to FIGS. 7A and 7B, an alternate embodiment of an elevatorinstrument 710 for use in subperiosteal augmentation procedures isshown. The instrument 710 includes a handle 711, a shaft 712 extendingfrom the handle 711, with a tip 713 at the end of the shaft 712. Theshaft 712 includes a plurality of shank sections, which in theembodiment depicted are first through fourth shank portions 712 c′, 712c″, 712 c″′, 712 c″″, and 712 c″″′, respectively. The shank 712 includesa plurality of bends, which from the proximal shank end to the distalshank end where the tip 713 is located, are depicted as a first bend 712d, a second bend 712 e, and a third bend 712 f, and a fourth bend 712 g.The first bend 712 d and second bend 712 e are on the same axis, whichare in a plane parallel to the central axis A. The third bend 712 f isprovided transverse to the central axis A. Preferably, the third ordistal bend 712 f is provided on a transverse axis, the transverse axisbeing represented by axis A2. The first shank portion 712 c′ is providedcoaxial with the central axis A. The second shank portion 712 c″ bendsrelative to the first portion 712 c′ at the first bend 712 d, and is inthe same axial plane as the first portion 712 c′. The third shankportion 712 c′″ bends relative to the second shank portion 712 c″ at thesecond bend 712 e, and then joins the fourth shank portion 712 c″″ atthe third bend 712 f At the third bend 712 f, however, the fourthportion 712 c″″ bends relative to the third portion 712 c″′ in adifferent axial plane than the first portion 712 c′, second portion 712c″ and third portion 712 c″′ and the respective first and second bends712 d, 712 e. The fifth shank portion 712 c″″′ bends relative to thefourth shank portion 712 c″″, at the fourth bend 712 g. The fifth shankportion 712 c″″′ bends at the fourth bend 712 g relative to the fourthshank section 712 c′′. The relative bend is along angle Z represented inFIG. 7B, between the fourth shank portion 712 c″″ and the fifth shankportion 712 c″″′. As illustrated in the top view of FIG. 7A, the fourthshank portion 712 c″″ and the fifth shank portion 712 c″″′ may haveshaft segments that are coplanar, although other shaft segments may bendmaking at least some of the respective lengths of the fourth shankportions 712 c″″ and the fifth shank portion 712 c″″′ in differentplanes. The bend of the third portion 712 c″′ which is on a transverseaxis A2, is shown in FIG. 7B represented by the angular bend where thethird portion 712 c′″ makes an angle Y relative to the second portion712 c″ and the central axis A.

The instrument 710 is shown with a tip 713 at the end of the fifth shankportion 712 c″″′. The tip preferably is configured to provide anengaging structure for engaging one or more of the tissue or the bonegraft material. According to the exemplary embodiment shown, the tip 713is configured in a fan like configuration, similar to the tip 513,having an inner surface 713 a that is concave. The concave surface 713 apreferably is substantially almost parallel to the handle 711. The backof the surface 713 b may be convex or flat.

According to a preferred embodiment, the second end includes a secondshank 722, which includes first through fifth shank portion 722 c′, 722c″, 722 c′″, 722 c″″ and 722 c″″′, respectively, and respective bends722 d, 722 e, 722 f and 722 g, similar to the arrangement of bends andshank sections shown in the first end of the instrument 710. A tip 723is provided at the distal end of the shank 722. The tips 713 and 723,are depicted similar to the tip 523 of FIGS. 2A and 2B, but are orientedas shown in FIGS. 7A and 7B. The angular bend of the fifth portion 712c″″′ orients the tip 713 is a preferred direction for utilization duringthe subperiosteal augmentation and reconstruction procedures. The tip723 is configured as a fan shape, where the tip portion 723 a joiningwith the shank shaft 722 at the proximal tip end is configured as anarrower portion, and, from that point distally, the tip 723 widens andfans out so that the wider portion of the tip 723 is at the tip end 723e.

According to embodiments, the instrument 710 preferably is constructedwith preferred angular dimensions, including a first angle defining afirst bend, which is a bend between the first portion 712 c′ and thesecond portion 712 c″, and a second angle defining a second bend whichis the bend between the second portion 712 c″ and the third portion 712c′″, and a third angle defining a third bend which is the bend betweenthe third portion 712 c′″ and the fourth portion 712 c″″, and a fourthangle defining a fourth bend which is the bend between the fourthportion 712 c″″ and the fifth portion 712 c″″′.

According to a preferred embodiment, the instrument 710 preferably isconstructed with the fifth portion 712 c″″′ being longer than each ofthe other four portions (712 c′, 712 c″, 712 c″′ and 712 c″″). The firstportion 712 c′, second portion 712 c″, third portion 712 c″′, and fourthportion 712 c″″, may each have similar lengths. For purposes ofdescribing the length of the first portion 712 c′, the tapered portion711 b of the handle 711 is included in this measurement portion.According to a preferred embodiment, the first, second, third and fourthshank portions 712 c′, 712 c″, 712 c′″ and 712 c″″, respectively, areeach about 10 mm in length. According to a preferred embodiment, thefourth portion may be slightly longer than the first, second or thirdportions (such as 12 mm for the fourth portion length and 10 mm for eachof the first, second and third portion lengths). The fifth portion 712c″′ inclusive of the tip 713 preferably is about 20 mm. The tip 713preferably has a length of about 4.5 mm. The fifth portion 712 c″″′, mayextend in a longitudinal direction relative to the fourth portion 712c″″ (as shown by the portion of the fifth portion 712 c″″′ in FIG. 7Abetween the fourth portion 712 c″″ and the tip 713), so that about 40percent of the fifth shank portion 712 c″″′ is radially outward relativeto (or beyond) the relatively axial outward reach of the fourth shankportion 712 c″″. For example, the fifth shank portion 712 c″″′ shown inFIG. 7B may be about 20 mm, whereas, the portion of the fifth shankportion 712 c″″′ shown in FIG. 7A represents about 8 mm of that portion.

Referring to FIGS. 8A and 8B, an alternate embodiment of an instrument810 is shown. The instrument 810 is similar to the instrument 710,except that the first shank portion 812 c′ is longer than the second,third and fourth shank portions, 812 c″, 812 c′″, 812 c″″, respectively,providing an extended reach of the instrument within a subperiostealtunnel. The bends shown facilitate positioning and maneuvering theinstrument through a subperiosteal tunnel, and to present the tip 813for engagement with the structure within the tunnel or at the surgicalsite. According to a preferred embodiment, the first portion 812 c′ maybe about 20 to 40 percent longer than the length of the respectivesecond, third and fourth shank portions 812 c″, 812 c′″ and 812 c″″.According to a preferred embodiment, the length of the second, third andfourth and fifth shank portions, respectively, 812 c″, 812 c″′, 812 c″″and 812 c″″′, may be similar to dimensions discussed in connection withthe instrument 710, with the first portion 812 c′ being provided havinga length of about 14 mm, that is, a length longer than the secondthrough fourth portions. Alternatively, one or more of the second, thirdor fourth portions may be provided having a greater length. For example,the fourth portion 812 c″″ may be provided having a greater length, and,according to a preferred embodiment, may be about 12 mm in the exampledepicted in FIGS. 8A and 8B, where the first portion 812 c′ is about 14mm, the second and fourth portions 812 c″ and 812 c″″, are each about 12mm, and the third portion 812 c″ is about 10 mm. The fifth portion 812c″″′ including the tip 813 is about 20 mm.

Referring to FIGS. 9A, 9B and 9C, an instrument for conductingsubperiosteal augmentation and reconstruction procedures is depicted,configured as a condenser instrument 910 is shown having a handle 911with a body 911 a, a first tapered portion 911 b at one end of the body911 a, and a second tapered portion 911 c at the other end of the body911 a. The condenser has a shank 912, with a first shank shaft portion912 c′ and a second shank shaft portion 912 c″. The second shank shaftportion 912 c″ bends relative to the first shank shaft portion 912 c′ atan angle relative to the central axis A of the instrument 910. Accordingto a preferred embodiment, the bend is along the central axis A and thecentral axis A2 of the second shaft portion 912 c″, with angle alpha 910(α910) representing the angle of the bend. The instrument 910 depictedpreferably includes a rounded tip 913, which, according to a preferredembodiment, is oval shaped, with an oval face 913 a. The tip 913preferably extends from a narrower portion 913 b from the location wherethe tip 913 joins the distal end of the second shank shaft portion 912c″. The tip 913 widens from the narrower proximal portion 913 b distallyto the tip end 913 c. Preferably, the instrument tip 913 may have anoval shape, which may comprise an oval body with a thickness. Thethickness preferably may be cross-sectionally oval, or, according tosome embodiments, may be a flattened oval shape, with the oval shapebeing more pronounced closest to the distal tip end 913 c supporting thetip surface 913 a. Alternate views in FIGS. 9B-9C depict the condenserinstrument 910 and tip 913.

According to a preferred embodiment, an oval tip, such as, for example,the oval tip 913, may be constructed to have a ratio of a long diameterwidth to the short diameter (height) of about 9 to 5, and morepreferably from about 9 to 7 in the exemplary embodiment depicted.According to a preferred configuration, a condenser instrument 910 maybe configured with an oval tip 913 which, preferably at the tip surface913 a, has a long width diameter of 4.5 mm and a shorter or heightdiameter of about 3.5 mm. The thickness of the long width preferablynarrows from the tip surface 913 a toward the tip proximal end 913 b.The thickness of the short or height diameter also may narrow from thetip surface 913 a at the distal tip end 913 c to the proximal end 913 b.

The instrument 910 preferably has a second shank 922 on the oppositehandle end, shown comprising a first shank portion 922 c′ and secondshank portion 922 c″ with a second tip 923 joining the distal end of thesecond shank portion 922 c″. In the embodiment illustrated in FIGS. 9Ato 9C, the second tip 923 is provided as a smaller tip relative to thefirst tip 913. For example, according to a preferred embodiment, thesecond tip may be provided having a ratio of a long diameter width tothe short diameter (height) of about 9 to 5, and more preferably, in theexemplary embodiment depicted, from about 7 to 5. According to apreferred configuration, the second tip 923 may be constructed having along width diameter of 3.5 mm and a shorter or height diameter of about2.5 mm. The thickness of the long width preferably narrows from the tipsurface 923 a toward the tip proximal end 923 b. The thickness of theshort or height diameter also may narrow from the tip surface 923 a atthe distal tip end 923 c to the proximal end 913 b. A beveled or anglededge may be provided at the tip end 923 e near the tip surface 923 a. Asimilar beveled end (not shown) may also be provided on the first tip913. The shank 922 preferably also has a bend 912 d therein similar tothe shank 912 of the first end.

Referring to FIG. 10A, an alternate embodiment of an instrument 1010configured as a condenser is shown. The condenser instrument 1010 issimilar to the instrument 910 shown in FIG. 9A, but having an elongatedshank shaft 1012, with a bend 1012 d. The shank shaft first portion 1012c′ preferably may be provided similar to the shank shaft portion 912 c′of the instrument 910, but in the embodiment illustrated in FIG. 10A,the instrument 1010 has a longer reach due to a longer shank shaftsecond portion 1012 c″. The tip 1013 may be the same as the tip 913shown and described herein, which according to a preferred embodiment isconfigured as an oval shape. The instrument 1010 also has a handle 1011,with a handle body 1011 a, a tapered first portion 1011 b, and taperedsecond portion 1011 c. According to the embodiment illustrated, theinstrument 1010 is configured as a condenser, and the angle alpha 1010(α1010), is greater than the corresponding angle (α910) of theinstrument 910, to provide an extended reach. Preferably, the extensionof the tip 1013 may be axially away from the central axis A, an equaldistance as the axial distance of the tip 913 in the instrument 910 ofFIG. 9A, away from the central axis A of the instrument 910. Theinstrument 1010 also includes a second end, having a second shank 1022on the opposite side of the handle 1011. The second shank 1022 includesa shank shaft first portion 1022 c′, providing a longer reach similar tothe shank shaft first portion 1012 c′, and includes a second shank shaftportion 1012 c″ with a second tip 1023. The second tip 1023 preferablyis configured similar to the second tip 923 provided in connection withthe instrument 910.

Features discussed and shown herein in conjunction with one or moreembodiments of the devices may be combined with one or more features andimplemented together. In addition, although instruments are depictedwith shanks that may be of similar length at each handle end, shanks ofdifferent lengths may be provided, according to some alternateembodiments. In addition, as discussed above in connection with theshank 112, the outer surface of the instruments shown and describedherein, including on the shanks, may include a scale thereon thatprovides a depth indicator. Shanks preferably may have a series ofevenly spaced markings which may be visibly provided thereon to mark thedepth at a point along the shank, from the tip end. The marking depthindication provides a depth indication to the user when the instrumentis inserted in a subperiosteal tunnel or otherwise penetrates tissue, sothe user will know the penetration depth of the instrument (when theinstrument portion, such as the shank, is within the tunnel and notvisible to the user). While the devices of the invention have beendisclosed in detail, and the preferred embodiments and best mode forpractice of the invention have been similarly disclosed, the scope ofexclusive rights to which the invention is entitled is defined by theclaims appended hereto and by equivalents that perform substantially thesame function in substantially the same way to achieve the same result.

Referring to FIGS. 11A to 11C, a compactor 1110 is shown having a handle1111 with a first shank 1112 at the first handle end, and a tip 1113 atthe distal end of the shank 1112. The shank 1112 is shown comprising afirst shank portion 1112 c′ and a second shank portion 1112 c″, with afirst bend 1112 d at the first shank portion 1112 c′ joining the handle1111, and a second bend 1112 e where the first shank portion 1112 c′ andsecond shank portion 1112 c″ join. The tip 1113 is shown at the distalend of the second shank portion 1112 c″. The instrument 1110 isconfigured as a compactor, which may be utilized in a subperiostealtunnel and/or surgical site to compact tissue or bone material,including bone graft material. The instrument 1110 preferably isconfigured to be maneuverable within the mucosa and/or subperiostealtissue to apply a force in a desired direction that may be directed bymovements of the handle 1111. For example, the handle 1111 may bemanipulated by moving it forward or rearward angling it, and/or rotatingit, or by combinations of these movements consecutively, orsimultaneously, to direct the tip 1113. As shown in FIGS. 11A, 11B, 11C,the tip 1113 is oval in configuration with a substantially flat profile,having a thickness substantially less than the length and width of theoval. The tip 1113 and shank 1112 (or portion thereof) may be introducedin a subperiosteal tunnel and may be maneuvered to compact the graft.For example, where graft material is introduced at a remote surgicalsite, the instrument shank 1112 may be directed through a tunnel and tothe surgical site, where the tip 1113 can be manipulated, preferably viathe handle 1111, to engage the graft material at the surgical site.Preferably, the tip 1113 is linear and is aligned with the axis of thesecond shank portion 1112 c″ to which the tip 1113 is joined.

According to preferred embodiments, the instrument 1110 may be providedwith markings on the shank. Preferably, the markings are provided on alinear scale to mark the linear distance from the tip to a location onthe shank 1112. For example, according to a preferred embodiment, themarkings may be designated in units, such as millimeters, and may bemarked periodically, such as every 1 mm, 3 mm, 5 mm, or otherarrangement. The marking indicia may be etched, engraved, or applied byother suitable marking methods, suitable for being able to insert themarked shank 1112 into tissue, including a subperiosteal tunnel andsurgical site. The linear markings, for example, measure a length alongthe instrument central axis, from the tip end 1113 e. As shown in FIG.11B, the markings are linear, and therefore, any measurements arecontinued to be measured linear, along the central axis, and in theembodiment illustrated, are not necessarily measured from the axis ofthe shank 1112 (which has a greater length than the portion of theinstrument central axis that the shank 1112 spans).

According to a preferred embodiment, the oval tip 1113 may be providedhaving a length that is axially longer than the width, as illustrated inFIGS. 11A-11C. One preferred ratio of the length to width is about 11 to8. For example, according to a preferred instrument embodiment, the ovalmay have a length of 5.5 mm and a width of about 4 mm. The instrument1110 is shown having a thickness that is less than the width of theoval. Some preferred embodiments provide a thickness that is about 1 to3 mm in thickness, and more preferably from about 1.5 to 2.5 mm.

The compactor instrument 1110 preferably is configured with a secondshank portion 1112 c″ that is longer than the first shank portion 1112c′. The first shank portion 1112 c′ preferably, at the first bend 1112 dis angularly bent relative to the handle 1111, as measured in referenceto the instrument central axis A and the central axis A1 of the firstshank portion 1112 c′ at an angle alpha (1110α2). The first angle 1110α2preferably is provided to be less than about 45 degrees, and morepreferably, between about 15 and 35 degrees.

The second shank portion 1112 c″ preferably, at the second bend 1112 eis angularly bent relative to the first shank portion 1112 c′, at anangle beta (1110β), as measured between the central axis A2 of thesecond shank portion 1112 c″ and the central axis A1 of the first shankportion 1112 c′. The second angle 1110β preferably is provided to begreater than the first angle alpha (1110α2). The second angle 1110βpreferably is less than 180 degrees, and more preferably is betweenabout 120 to 170 degrees. According to preferred embodiments, thecompactor 1110 preferably may have a second end with a second shank 1122extending from the handle 1111. According to some embodiments, thesecond shank 1122 may be constructed similar to the first shank 1112,with a second tip 1123 provided on the second shank portion 1122 c″, andwith the second shank portion 1122 c″ being provided at a bend 1122 dwhere the second shank portion 1122 c″ joins the first shank portion1122 c′. The first shank portion 1122 c′ is shown extending from thehandle 1111. The second tip 1123 may be configured to be the same as thefirst tip 1113. According to some alternate embodiments, the second tip1123 may be different than the first tip 1113. For example, the secondtip may be provided having a different size, where the tip is relativelysmaller or larger. The second tip may maintain proportions of the firsttip oval configurations (and/or thicknesses) although it may be smalleror larger in some alternate embodiments. According to some otherembodiments, the second tip may be provided with different proportions,and/or thicknesses.

According to a preferred embodiment, the compactor 1110 is constructedwith the portion of the shank shaft 1112 c between the first bend 1112 dand second bend 1112 e being about 14 mm, and with the portion betweenthe second bend 1112 e to the tip 1113, inclusive of the tip length,being about 22 mm. Similarly, the second shank 1122 c may be constructedwith similar dimensions.

Referring to FIGS. 12A and 12B, an alternate embodiment of an instrument1210 configured as a compactor is shown. The compactor instrument 1210is similar to the compactor instrument 1110 of FIGS. 11A, 11B and 11C,except that each shank 1212, 1223 is longer, and the angles of the shankbends, the first angle alpha (1210α2) and second angle beta (1210β) inthe instrument 1210 are provided to produce less of a bend. The firstangle alpha (1210α2) of the instrument 1210 is less than thecorresponding angle (1110α2) of the instrument 1110. The second anglebeta (1210β) of the instrument 1210 is greater than the second anglebeta (1110β) of the instrument 1110. The first shank shaft portion 1212c′ on the first end of the instrument 1210 is longer in relation to thefirst shank shaft portion 1112 c′ in the instrument 1110 depicted inFIGS. 12A and 12B, as is the second shank portion 1212 c″ which islonger than the corresponding second shank portion 1112 c″ of theinstrument 1110. In the longer instrument 1210, the tip 1213 is distallyfurther from the handle 1211. The shank 1212 is constructed to have lesspronounced angular bends at the first bend 1212 d and second bend 1212 eso as to provide a maximum instrument width that includes deviationsfrom the central axis A, on either side. According to some embodiments,the axial width or window for the instrument 1110 may be the same windowas for the instrument 1210, with the additional shank length beingaccommodated by a reduction in the outward deviation of the shaftrelative to the central axis A. The second instrument end includes asecond tip 1223 provided at the end of the second shaft 1222. The secondshaft 1222 extends from the handle 1211, and preferably from the taperedportion 1211 c and to where it joins the tip 1223 at the distal shankend. Similar to the first shaft portion 1212 c′ and second shaft portion1212 c″ of the first shaft 1212, the second shaft 1222 includes a firstshaft portion 1222 c′ and second shaft portion 1222 c″.

According to a preferred embodiment, the compactor 1210 is constructedwith the portion of the shank shaft 1212 c between the first bend 1212 dand second bend 1212 e being about 19 mm, and with the portion betweenthe second bend 1212 e to the tip 1213, inclusive of the tip length,being about 27 mm. Similarly, the second shank 1222 c may be constructedwith similar dimensions. In a preferred embodiment, each oval tip 1213,1223, preferably, is similar to the oval tip 1113 and 1123 of theinstrument 1110. According to a preferred embodiment, the tips 1213 and1223, may be about 5.5 mm in length, with a width of about 4 mm.

According to preferred embodiments, the instrument tips, such as, forexample, the tips 1113, 1123, 1213, and 1223, preferably are oval inconfiguration and may have a tapered thickness, which may be wedgeshaped, as illustrated in the side views of FIGS. 11A and 12A, for therespective instruments 1110 and 1210. The tapered tip 1113, for example,may be provided with both sides being tapered to converge. For example,according to the embodiment illustrated in FIG. 11B, the tip surfacesare shown converging toward the axis A from the proximal tip end to thedistal tip end. Similarly, the tip 1213 of the instrument 1210 shown inFIG. 12B is shown with the converging surfaces. The tips of the otherends of the instruments (1123 and 1223) also may be similarlyconfigured. According to some alternate embodiments, a single side ofthe tip 1113 may converge and the other side may remain axiallystraight. Preferably, the tip 1113 includes an end portion with asurface 1113 e for engaging with material, such as, for example, bonegraft material, to position or compact the material into place.

Features discussed and shown herein in conjunction with one or moreembodiments of the devices may be combined with one or more features andimplemented together. In addition, although instruments are depictedwith shanks that may be of similar length at each handle end, shanks ofdifferent lengths may be provided, according to some alternateembodiments. In addition, as discussed above in connection with theshank 112, the outer surface of the instruments shown and describedherein, including on the shanks, may include a scale thereon thatprovides a depth indicator. Shanks preferably may have a series ofevenly spaced markings which may be visibly provided thereon to mark thedepth at a point along the shank, from the tip end. The marking depthindication provides a depth indication to the user when the instrumentis inserted in a subperiosteal tunnel or otherwise penetrates tissue, sothe user will know the penetration depth of the instrument (when theinstrument portion, such as the shank, is within the tunnel and notvisible to the user). While the devices of the invention have beendisclosed in detail, and the preferred embodiments and best mode forpractice of the invention have been similarly disclosed, the scope ofexclusive rights to which the invention is entitled is defined by theclaims appended hereto and by equivalents that perform substantially thesame function in substantially the same way to achieve the same result.

What is claimed is:
 1. A surgical instrument for compacting bone graftmaterial, subperiosteal tunneling and bone grafting procedures,comprising: a) a handle; b) a shank extending from the handle; c) a tipprovided on the shank; d) wherein, upon moving said handle, said shankis configured to manipulate the tip in one or more directions; e)wherein said tip has a thickness, and f) wherein said tip terminateshaving a blunt end.
 2. The surgical instrument of claim 1, wherein theinstrument has a central axis, and wherein the thickness of said tipdecreases distally from a point along the central axis of the tip to thetip end, and starting from a location along the central axis of the tipthat is proximally distant from said tip blunt end.
 3. The surgicalinstrument of claim 1, wherein the tip has a proximal end and a distalend, the distal end defining a leading end of the tip and comprisingsaid blunt end, and wherein said tip joins with the shank at the tipproximal end.
 4. The surgical instrument of claim 1, wherein the tip hasan oval configuration and wherein the tip thickness is greatest at alocation along the longitudinal center of the tip, as determined alongan axial centerline of the instrument.
 5. The surgical instrument ofclaim 4, wherein said oval tip has first and second lateral edges thatjoin at said distal end to form said blunt end, wherein the oval tip hasa thickness, and wherein said oval tip decreases in thickness from acenter location of the oval tip to each of said first and second lateraledges.
 6. The surgical instrument of claim 1, wherein said tip isprovided with a first side and a second side, and wherein said secondside comprises a flat side.
 7. The surgical instrument of claim 6,wherein said flat side comprises a flat surface.
 8. The surgicalinstrument of claim 7, wherein said instrument has an axis, wherein saidtip has a distal end and a proximal end, the proximal end joining withsaid shank and the distal end forming the blunt end of the tip andinstrument end.
 9. The surgical instrument of claim 8, wherein said tipfirst side has a first surface that is convex and wherein said tipsecond side has a second surface that is flat, and wherein said tipfirst side convex surface converges toward the second side surface froman axial point along the tip to the tip distal end.
 10. The surgicalinstrument of claim 1, wherein said handle rotation imparts a force fromsaid tip in a direction different than the handle movement.
 11. Thesurgical instrument of claim 1, wherein said tip comprises an ovalconfiguration having an arcuate periphery with a blunt end provided onsaid arcuate periphery.
 12. The surgical instrument of claim 9, whereinsaid tip has a first lateral edge and a second lateral edge, whereineach of said first lateral edge and said second lateral edge joins withsaid shank at one end thereof and extends laterally to said tip end. 13.The surgical instrument of claim 12, wherein each of said first lateraledge and said second lateral edge span laterally outward relative to theinstrument centerline to a maximum outward position relative to saidcenterline, and wherein each of said first lateral edge and said secondlateral edge span laterally inward relative to the instrument centerlinefrom said maximum outward position toward the tip end.
 14. The surgicalinstrument of claim 13, wherein said tip has an oval configuration, andwherein said blunt end has a curvature.
 15. The surgical instrument ofclaim 13, wherein said instrument has an axial centerline, wherein saidshank includes at least one bend therein, wherein said at least one bendcrosses said axial centerline in at least one location along said axialcenterline, and wherein said tip is located at said axial centerline orcrosses over said axial centerline.
 16. The surgical instrument of claim9, wherein said shank comprises a first shank and a second shank, andwherein said handle has a first end and a second end, with the firstshank at said first handle end and the second shank at said secondhandle end, and wherein said tip comprising said oval configurationcomprises a first tip provided at the end of said first shank, andwherein a second tip comprising an oval configuration is provided at theend of said second shank, said second tip comprising an ovalconfiguration and having an arcuate periphery with a blunt end providedon said arcuate periphery.
 17. The surgical instrument of claim 16,wherein said first shank and said first tip comprise a unitarycontinuous structure extending from the first handle end, and whereinsaid second shank and said second tip comprise a unitary continuousstructure extending from the second handle end.
 18. The surgicalinstrument of claim 1, wherein said tip has an end, and wherein saidshank has markings provided thereon that indicate the depth of saidmarking to the tip end.
 19. The surgical instrument of claim 9, whereinthe instrument has a longitudinal central instrument axis A, whereinsaid shank has a first bend and a second bend, wherein said shankincludes a shank first portion that meets the shank second portion atthe second bend, wherein the shank at the first bend is angled away fromthe instrument central axis A, at an angle represented by a first anglealpha (α2), wherein the shank second portion bends inwardly toward theinstrument central axis A relative to the first shank portion at asecond angle represented by angle beta (β) where angle beta (β) is theangle between the first shank portion and the second shank portion, andwherein the first angle alpha (α2), that the shank first portion makeswith the instrument central axis A, is relatively smaller than thesecond angle beta (β) that the shank first portion makes with the shanksecond portion.
 20. The surgical instrument of claim 19, wherein thefirst angle alpha (α2) is between 15 to 45 degrees, and whereas thesecond angle beta (β) is between 120 to 180 degrees.
 21. The surgicalinstrument of claim 19, wherein the first angle alpha (α2) is about 30degrees, and whereas the second angle beta (β) is about 120 degrees.